BRPI0307056B1 - Composição farmacêutica sólida orodispersível de ivabradina, comprimido e utilização de grânulos que consistem em lactose e amido co-secos - Google Patents

Composição farmacêutica sólida orodispersível de ivabradina, comprimido e utilização de grânulos que consistem em lactose e amido co-secos Download PDF

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Publication number
BRPI0307056B1
BRPI0307056B1 BRPI0307056-5A BR0307056A BRPI0307056B1 BR PI0307056 B1 BRPI0307056 B1 BR PI0307056B1 BR 0307056 A BR0307056 A BR 0307056A BR PI0307056 B1 BRPI0307056 B1 BR PI0307056B1
Authority
BR
Brazil
Prior art keywords
ivabradine
pharmaceutical composition
tablet
starch
pharmaceutically acceptable
Prior art date
Application number
BRPI0307056-5A
Other languages
English (en)
Portuguese (pt)
Other versions
BR0307056A (pt
Inventor
Patrick Wuthrich
Hervé Rolland
Marc Julien
Original Assignee
Servier Lab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Servier Lab filed Critical Servier Lab
Publication of BR0307056A publication Critical patent/BR0307056A/pt
Publication of BRPI0307056B1 publication Critical patent/BRPI0307056B1/pt

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Saccharide Compounds (AREA)
  • Other In-Based Heterocyclic Compounds (AREA)
BRPI0307056-5A 2002-01-23 2003-01-22 Composição farmacêutica sólida orodispersível de ivabradina, comprimido e utilização de grânulos que consistem em lactose e amido co-secos BRPI0307056B1 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0200791A FR2834896B1 (fr) 2002-01-23 2002-01-23 Composition pharmaceutique orodispersible d'ivabradine
PCT/FR2003/000198 WO2003061662A1 (fr) 2002-01-23 2003-01-22 Composition pharmaceutique orodispersible d'ivabradine

Publications (2)

Publication Number Publication Date
BR0307056A BR0307056A (pt) 2004-10-26
BRPI0307056B1 true BRPI0307056B1 (pt) 2015-06-30

Family

ID=27589555

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0307056-5A BRPI0307056B1 (pt) 2002-01-23 2003-01-22 Composição farmacêutica sólida orodispersível de ivabradina, comprimido e utilização de grânulos que consistem em lactose e amido co-secos

Country Status (28)

Country Link
US (2) US20050106238A1 (ko)
EP (1) EP1474152B1 (ko)
JP (1) JP4500052B2 (ko)
KR (1) KR100613550B1 (ko)
CN (1) CN1278688C (ko)
AR (1) AR038206A1 (ko)
AT (1) ATE348619T1 (ko)
AU (1) AU2003215706B2 (ko)
BR (1) BRPI0307056B1 (ko)
CA (1) CA2473203C (ko)
CY (1) CY1108854T1 (ko)
DE (1) DE60310526T2 (ko)
DK (1) DK1474152T3 (ko)
EA (1) EA007681B1 (ko)
ES (1) ES2278165T3 (ko)
FR (1) FR2834896B1 (ko)
GE (1) GEP20063820B (ko)
HK (1) HK1076741A1 (ko)
MA (1) MA27102A1 (ko)
MX (1) MXPA04007199A (ko)
NO (1) NO333698B1 (ko)
NZ (1) NZ533842A (ko)
PL (1) PL204938B1 (ko)
PT (1) PT1474152E (ko)
SI (1) SI1474152T1 (ko)
UA (1) UA78278C2 (ko)
WO (1) WO2003061662A1 (ko)
ZA (1) ZA200405129B (ko)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2868777B1 (fr) * 2004-04-13 2006-05-26 Servier Lab Nouveau procede de synthese de l'ivabradine et de ses sels d'addition a un acide pharmaceutiquement acceptable
FR2882553B1 (fr) * 2005-02-28 2007-05-04 Servier Lab Forme cristalline beta du chlorhydrate de l'ivabradine, son procede de preparation, et les compositions pharmaceutiques qui la contiennent
WO2007023775A1 (ja) * 2005-08-23 2007-03-01 Astellas Pharma Inc. 心房細動治療剤
FR2894825B1 (fr) * 2005-12-21 2010-12-03 Servier Lab Nouvelle association d'un inhibiteur du courant if sinusal et d'un inhibiteur de l'enzyme de conversion et les compositions pharmaceutiques qui la contiennent
FR2911279B1 (fr) * 2007-01-11 2009-03-06 Servier Lab Utilisation de l'ivabradine pour l'obtention de medicaments destines au traitement de la dysfonction endotheliale
WO2010128525A2 (en) 2009-05-04 2010-11-11 Dinesh Shantilal Patel A formulation of ivabradine for treating the cardiovascular disease
US20130084335A1 (en) 2010-06-14 2013-04-04 Ratiopharm Gmbh Ivabradine-containing pharmaceutical composition
CN103393611B (zh) * 2013-08-06 2015-08-19 南京正大天晴制药有限公司 一种盐酸伊伐布雷定片剂及其制备方法
WO2016102423A1 (en) * 2014-12-22 2016-06-30 Ratiopharm Gmbh Composition comprising ivabradine in a dissolved form
GR1008821B (el) 2015-06-11 2016-08-01 Φαρματεν Ανωνυμος Βιομηχανικη Και Εμπορικη Εταιρεια Φαρμακευτικων Ιατρικων Και Καλλυντικων Προϊοντων Φαρμακευτικο σκευασμα που περιλαμβανει υδροχλωρικη ιβαμπραδινη και μεθοδος παρασκευης αυτου
CN106265582A (zh) * 2016-08-31 2017-01-04 辰欣药业股份有限公司 一种盐酸伊伐布雷定片及其制备工艺
WO2021001601A1 (en) * 2019-07-01 2021-01-07 Orion Corporation Methods for administering (r)-n-[4-(1,4,5,6-tetrahydro-6-oxo-3-pyridazinyl)phenyl]acetamide

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT376147B (de) * 1980-12-15 1984-10-10 Gergely Gerhard Verfahren und vorrichtung zum granulieren eines pulvergemisches
DE3505433A1 (de) * 1985-02-16 1986-08-21 Basf Ag, 6700 Ludwigshafen Direkttablettierhilfsmittel
DE3506276C1 (de) * 1985-02-22 1986-04-24 Meggle Milchindustrie Gmbh & Co Kg, 8094 Reitmehring Direkttablettiermittel
JP3253127B2 (ja) * 1991-06-07 2002-02-04 帝國製薬株式会社 生理活性ポリペプチド含有製剤
FR2681862B1 (fr) * 1991-09-27 1993-11-12 Adir Cie Nouvelles (benzocycloalkyl)alkylamines, leur procede de preparation, et les compositions pharmaceutiques qui les contiennent.
FR2710265B1 (fr) * 1993-09-22 1995-10-20 Adir Composition pharmaceutique bioadhésive pour la libération contrôlée de principes actifs.
CA2179382C (en) * 1994-01-31 2009-11-10 Takao Mizumoto Intrabuccally dissolving compressed moldings and production process thereof
US6024981A (en) * 1997-04-16 2000-02-15 Cima Labs Inc. Rapidly dissolving robust dosage form
JP2001526662A (ja) * 1997-05-09 2001-12-18 フェロンパテント リミテッド 舌下投与式タブレットの製造のための水溶液におけるインターフェロンの安定化
AU741992B2 (en) * 1998-03-06 2001-12-13 Adare Pharmaceuticals S.R.L. Fast disintegrating tablets
JP2983973B1 (ja) * 1998-10-13 1999-11-29 大正薬品工業株式会社 口腔内速崩壊性固形製剤
JP2000273039A (ja) * 1999-01-20 2000-10-03 Taisho Pharmaceut Co Ltd 口腔内崩壊性組成物
JP2001058944A (ja) * 1999-06-18 2001-03-06 Takeda Chem Ind Ltd 速崩壊性固形製剤
DE60036205T2 (de) * 2000-07-27 2008-05-21 Roquette Frères Granulat bestehend aus Stärke und Laktose
UA80393C2 (uk) * 2000-12-07 2007-09-25 Алтана Фарма Аг Фармацевтична композиція, яка містить інгібітор фде 4, диспергований в матриці
FR2818552B1 (fr) * 2000-12-26 2003-02-07 Servier Lab Compositions pharmaceutique solide thermoformable pour la liberation controlee d'ivabradine
FR2834889B1 (fr) * 2002-01-18 2004-04-02 Roquette Freres Forme pharmaceutique solide orodispersible

Also Published As

Publication number Publication date
ATE348619T1 (de) 2007-01-15
CN1278688C (zh) 2006-10-11
CA2473203A1 (fr) 2003-07-31
WO2003061662A1 (fr) 2003-07-31
MXPA04007199A (es) 2004-10-29
CY1108854T1 (el) 2014-07-02
FR2834896A1 (fr) 2003-07-25
SI1474152T1 (sl) 2007-04-30
ES2278165T3 (es) 2007-08-01
HK1076741A1 (en) 2006-01-27
JP4500052B2 (ja) 2010-07-14
UA78278C2 (en) 2007-03-15
PL370161A1 (en) 2005-05-16
EP1474152A1 (fr) 2004-11-10
EA200400927A1 (ru) 2004-12-30
AR038206A1 (es) 2005-01-05
GEP20063820B (en) 2006-05-10
CN1622809A (zh) 2005-06-01
DE60310526D1 (de) 2007-02-01
AU2003215706B2 (en) 2007-08-02
NO333698B1 (no) 2013-08-26
NO20043440L (no) 2004-08-18
DK1474152T3 (da) 2007-04-10
KR100613550B1 (ko) 2006-08-16
AU2003215706B8 (en) 2003-09-02
FR2834896B1 (fr) 2004-02-27
ZA200405129B (en) 2005-08-31
US20100267693A1 (en) 2010-10-21
KR20040075366A (ko) 2004-08-27
DE60310526T2 (de) 2007-10-25
US20050106238A1 (en) 2005-05-19
EA007681B1 (ru) 2006-12-29
JP2005523893A (ja) 2005-08-11
PT1474152E (pt) 2007-02-28
PL204938B1 (pl) 2010-02-26
MA27102A1 (fr) 2004-12-20
EP1474152B1 (fr) 2006-12-20
NZ533842A (en) 2005-08-26
BR0307056A (pt) 2004-10-26
CA2473203C (fr) 2010-08-17

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: PARA: INT. CL. A61K 31/55, 9/20; A61P 9/00

Ipc: A61K 31/55 (2011.01), A61K 9/20 (2011.01), A61P 9/

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: PAGAR RESTAURACAO.

B08H Application fees: decision cancelled [chapter 8.8 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 NA RPI 2287 DE 04/11/2014.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 30/06/2015, OBSERVADAS AS CONDICOES LEGAIS.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 17A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2550 DE 19-11-2019 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.